Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00064142
Status:
COMPLETED
Last Update Posted:
2013-06-05
First Post:
2003-07-08
Brief Title:
Halofuginone Hydrobromide in Treating Patients With HIV-Related Kaposis Sarcoma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Trial of Topical Halofuginone in Patients With HIV Related Kaposis Sarcoma
Status:
COMPLETED
Status Verified Date:
2013-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase II trial studies how well halofuginone hydrobromide works in treating patients with human immunodeficiency virus HIV-related Kaposis sarcoma Halofuginone hydrobromide ointment may stop the growth of Kaposis sarcoma by stopping blood flow to the tumor
Detailed Description:
PRIMARY OBJECTIVES
I To determine the tumor response rate of acquired immune deficiency syndrome AIDS-related Kaposis sarcoma to topical halofuginone halofuginone hydrobromide versus vehicle control
II To evaluate the safety and tolerability of topical halofuginone and vehicle in patients with AIDS-related Kaposis sarcoma
SECONDARY OBJECTIVES
I To determine the ability of topical halofuginone to inhibit expression of matrix metallopeptidase 2 MMP-2 and Collagen type I in AIDS-related Kaposis sarcoma
II To explore the relationship between baseline cluster of differentiation CD 4 and CD8 counts HIV viral load and human herpesvirus 8 HHV-8 viral load and response to halofuginone
III To characterize the pharmacokinetics of halofuginone
OUTLINE Twelve treatable Kaposis sarcoma lesions are selected on each patient and these 12 lesions are randomized equally to 1 of 2 treatment arms 6 lesions receive study treatment and 6 lesions receive placebo each patient serves as hisher own control
ARM I Patients apply topical halofuginone hydrobromide ointment to each of 6 lesions twice a day for 12 weeks
ARM II Patients apply topical placebo ointment to each of 6 lesions twice a day for 12 weeks
Patients with stable or responding disease in either or both groups of treated lesions halofuginone hydrobromide ointment or placebo ointment may receive open-label treatment with topical halofuginone hydrobromide ointment to all 12 lesions for an additional 12 weeks as above in the absence of disease progression or unacceptable toxicity
Patients are followed for at least 1 month
I To determine the tumor response rate of acquired immune deficiency syndrome AIDS-related Kaposis sarcoma to topical halofuginone halofuginone hydrobromide versus vehicle control
II To evaluate the safety and tolerability of topical halofuginone and vehicle in patients with AIDS-related Kaposis sarcoma
SECONDARY OBJECTIVES
I To determine the ability of topical halofuginone to inhibit expression of matrix metallopeptidase 2 MMP-2 and Collagen type I in AIDS-related Kaposis sarcoma
II To explore the relationship between baseline cluster of differentiation CD 4 and CD8 counts HIV viral load and human herpesvirus 8 HHV-8 viral load and response to halofuginone
III To characterize the pharmacokinetics of halofuginone
OUTLINE Twelve treatable Kaposis sarcoma lesions are selected on each patient and these 12 lesions are randomized equally to 1 of 2 treatment arms 6 lesions receive study treatment and 6 lesions receive placebo each patient serves as hisher own control
ARM I Patients apply topical halofuginone hydrobromide ointment to each of 6 lesions twice a day for 12 weeks
ARM II Patients apply topical placebo ointment to each of 6 lesions twice a day for 12 weeks
Patients with stable or responding disease in either or both groups of treated lesions halofuginone hydrobromide ointment or placebo ointment may receive open-label treatment with topical halofuginone hydrobromide ointment to all 12 lesions for an additional 12 weeks as above in the absence of disease progression or unacceptable toxicity
Patients are followed for at least 1 month
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U01CA070019 | NIH | None | httpsreporternihgovquickSearchU01CA070019 |
| AMC-036 | None | None | None |
| CDR0000309055 | None | None | None |